Country of Origin or Made In Tags - Where a country is a principality

F

fialor

Involved In Discussions
Here is a fun dilemma for all:

Where a country is a principality, like Monaco is of France, does one reference France as the country in the "Made In" tag on the product, or does one reference Monaco itself?

Fialor
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Re: Country of Origin or Made In Tags

Fialor, does this question pertain to medical devices made in Monaco or is this more of a general water cooler question?
 
shimonv

shimonv

Trusted Information Resource
Re: Country of Origin or Made In Tags

I say the country of origin needs to be consistent with the address of the manufacturer. In the case on Monaco there shouldn't be a problem commercializing the product in the EU after approval, but if you intend to reach out to LATAM and Asian countries - the country of manufacturing must consistent throughout your product labeling, ISO certificate, CE certificate, Quality agreements, etc. In short - don't be smart; be precise.
 
F

fialor

Involved In Discussions
Re: Country of Origin or Made In Tags

Thanks Shimony.
There is an added complication in that the manufacturer's address is different to the place of manufacture.
Diana
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Re: Country of Origin or Made In Tags

If the manufacturer's address (Company 1) is different than the place of manufacture (Company 2), then isn't the product made in the place by Company 2 and distributed by the address of Company 1?
 
F

fialor

Involved In Discussions
Re: Country of Origin or Made In Tags

Thanks Roxane.
No - Company A physically makes the device but Company B is the legal manufacturer (not distributor). Company A is in Monaco but Company B is elsewhere (not in Monaco ).
 
shimonv

shimonv

Trusted Information Resource
Re: Country of Origin or Made In Tags

I see.. then use the address of the legal manufacturer (the person placing the device on the market) as your primary contact point and country of origin.
 
F

fialor

Involved In Discussions
Re: Country of Origin or Made In Tags

shimonv said:
I see.. then use the address of the legal manufacturer (the person placing the device on the market) as your primary contact point and country of origin.
Click to expand...
Thanks for the reply Shimony.
But I think we went off topic for minute :)
My question was whether I can reference made in as France though product is made in Monaco which is a principality of France.
 
P

Pads38

Moderator
Re: Country of Origin or Made In Tags

The country in which your device is 'made' is the country in which the legal manufacturer exists.

That it is 'bolted together' in Monaco is not relevant.
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Re: Country of Origin or Made In Tags

From the European Commission Health and Consumers Directorate-General for Health Systems and Products, and Medicinal Products :

VOLUME 2A
Procedures for marketing authorisation
CHAPTER 1
MARKETING AUTHORISATION
June 2013

Monaco

An agreement between the Union and the Principality of Monaco entered into force on 1 May 2004, Council Decision 2003/885/EC of 17 November 2003 concerning the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco7. On the basis of this agreement and the special arrangements agreed between France and the Principality of Monaco in an agreement of 6 January 2003, the French authorities assume the role of competent authorities as far as the application of the medicinal products legislation to products manufactured in Monaco is concerned. The French authorities are responsible for the issue of
marketing authorisations for Monaco and conduct inspections on manufacturing sites of medicinal products in Monaco. Batches from Monaco have to be considered as batches which have already undergone controls in a Member State and are therefore exempted from further controls and retesting. The batches may be regarded as released in France, though the place of manufacturing sites is in Monaco.
Click to expand...

The bolded text has been bolded by me. Granted this particular document appears to focus on medicinal products, not sure if that applies to medical devices.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Certificate of Conformance for Country of Origin - Made in the USA claim Contract Review Process 16
MDD_QNA Country of origin - Made in EU or Made in Finland? EU Medical Device Regulations 1
T FTC "Made In U.S.A" Labeling Rules vs. Saudi Arabia's "Country of Origin" Regulations Other Medical Device Regulations World-Wide 6
O Country of origin EU Medical Device Regulations 2
A NMPA registered device VS country of origin (free sales certificate) China Medical Device Regulations 5
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
DMLqms Country of Origin on Commercial Invoices EU Medical Device Regulations 2
M Medical device country of origin Medical Device and FDA Regulations and Standards News 5
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
C Legal requirement for same indications as in Country of Origin Other Medical Device Regulations World-Wide 4
K Markets with No Prior Approvals? Without Country of Origin or other Prior Approval Other Medical Device Regulations World-Wide 5
G Country of Origin Medical Labeling - Foreign Content, Domestic Assembly Other US Medical Device Regulations 3
C Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling) Other US Medical Device Regulations 4
C Labeling Requirements and COO (Country of Origin) Other US Medical Device Regulations 13
P Is there a requirement for country of origin on packaging of class 2a medical device? Other Medical Device and Orthopedic Related Topics 17
C Advice on "Country of Origin" regulation with regard to medical devices Other Medical Device and Orthopedic Related Topics 2
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
C Country registrations Other Medical Device Regulations World-Wide 3
B Auditor from other country ISO 14001:2015 Specific Discussions 5
L Article 87 Field Safety Corrective Actions in a third country EU Medical Device Regulations 2
R GB9706.1:2020 - in-country testing China Medical Device Regulations 3
Watchcat One UDI per country? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Country of Manufacturer Medical Device and FDA Regulations and Standards News 0
S Switzerland now requires an in-country Authorized Rep? EU Medical Device Regulations 2
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
A ISO 20417:2021 Country of Manufacture Medical Device and FDA Regulations and Standards News 6
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 6
R Vigilance reporting to the country of the EU authorised representative EU Medical Device Regulations 2
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
J In-Country Representative - Thailand Other Medical Device Regulations World-Wide 7
Z In which country is essential to have and IEC 60601 CB Report? Other Medical Device Related Standards 0
E How do you identify what standards a country recognizes outside of FDA, EU, Health Canada Other Medical Device Related Standards 1
P Notified body located in an other country than manufacturing company ISO 13485:2016 - Medical Device Quality Management Systems 2
K IoT, AI, Big Data and National Strategies of Other Countries (in your country, do you have any?) IEC 27001 - Information Security Management Systems (ISMS) 12
M Medical Device News EU - List of national market surveillance authorities by sector and country EU Medical Device Regulations 0
M Is "Made in (Country)" a labelling requirement? Other Medical Device Regulations World-Wide 8
F Class IIa/b in-country registrations x5 ? Other Medical Device Regulations World-Wide 1
rob73 Worldwide device regulatory authorities at country level Other Medical Device Regulations World-Wide 6
M Forced NOT to meet End Customer Expectations - Corrupt Third World Country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M IATF 16949 Cl. 8.4.2.2 - Country of Receipt - The provider's or supplier's country? IATF 16949 - Automotive Quality Systems Standard 5
M IATF:16949 Common Quality Manual - Company is in Country A and Country B Quality Management System (QMS) Manuals 5
L In which country do I certify my company? (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 14
M A non-religious country, where you don't drink? Coffee Break and Water Cooler Discussions 14
Q Efficient way to manage different country Medical Device Regulations Other US Medical Device Regulations 10
K Country/region specific medical device regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
M Correlation matrix of ISO 13485 and other country regulations Other ISO and International Standards and European Regulations 3
D Can country-specific regulatory timelines be shortened if the device has a CE mark? EU Medical Device Regulations 8
P Law restrictions in each country [REACH, CONFLICT MINERALS, Canada Gazette] RoHS, REACH, ELV, IMDS and Restricted Substances 2
K DFARS (Defense Federal Acquisition Regulations) Certs for a Qualifying Country Various Other Specifications, Standards, and related Requirements 2
0 ISO 9001:2008 interpretation not the same per country? (Netherlands and France) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom